The Food and Drug Administration (FDA) has reported that it has received 23 reports of adverse health effects in persons who have used the weight-loss product, Hydroxycut. Reported complications from using Hydroxycut include heart problems and a kind of muscle damage that could lead to kidney failure. One person suffering from severe side effects of Hydroxycut even required a liver transplant.
On May 1, 2009 the FDA issued a warning to consumers to stop using Hydroxycut. According to the FDA warning the manufacturer, Iovate Health Scientists of Oakville, Ontario, Canada and its American distributor, are recalling Hydroxycut. All in all, lovate is recalling 14 of its product line. This recall will not affect its products Hydroxycut Cleanse and Hoodia, which have different ingredients than the other products.
The Hydroxycut brand has been widely sold at national stores including Vitamin Shoppe and GNC. The product is sold in a form of pills, drinks and powders which is designed to increase energy, burn calories and fat, and control appetite. According to the FDA about nine millions units of the product were sold in 2008. Vitamin Shoppe and GNC reportedly are removing Hydroxycut products from their websites and stores.
The recall of one of the best known weight-loss brands is the latest in a series of incidents that raised questions as to whether or not the FDA has the authority to regulate the dietary supplement industry and provide consumers with protection.
Drugs that are distributed must provide safety and effectiveness data before receiving federal approval to be sold. However, dietary supplements do not need FDA approval to go on the market. Manufacturers of dietary supplements are themselves responsible for ensuring and documenting the safety of their claims related to these products. According to the law of governing supplements, the FDA is empowered to act only in cases where it identifies a harmful product that is already on sale.
“Part of the problem, as you know, is that FDA looks at dietary supplements from a post-market perspective, so that an isolated incident is often difficult to follow,” Dr. Linda Katz, interim chief medical officer of the agencies’ Center for Food Safety and Applied Nutrition.
The FDA has been on a campaign to warn consumers about dangerous weight loss pills that contain illegal drug ingredients. The FDA has a list of 70 brands that contain hidden or potentially dangerous drugs, including anti-seizure medication. A new law has made the FDA’s job a little easier by requiring manufacturers to notify the agency of any reports of serious health problems. This requirement helped FDA officials identify a pattern of adverse events linked to Hydroxycut users.
Several months ago distributors of the weight loss brand, StarCaps was found to contain a powerful prescription diuretic.
Kreisman Law Offices has been practicing pharmaceutical litigation and Illinois product liability law for over 30 years, serving Cook County and its surrounding areas including Chicago, Burbank, Glen Ellyn, and Arlington Heights.